Bayer HealthCare recently announced that the US Food and Drug Administration (FDA) has granted priority review of its pulmonary arterial hypertension (PAH) drug’s New Drug Application (NDA).
The oral investigational drug riociguat’s NDA was submitted for regulatory approval in the US and the European Union at the beginning of February as the first drug to demonstrate efficacy in two distinct forms of pulmonary hypertension: inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).
“In the pivotal Phase III studies, riociguat was shown to be the first drug therapy to demonstrate robust efficacy in two potentially fatal pulmonary hypertension indications,” Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development said in a statement. “To date, no approved pharmacological therapy exists for CTEPH and as a result there is an urgent unmet medical need for patients who are unable to undergo surgery. We hope that we will soon be in a position to provide patients and doctors with a new treatment option.”
In two randomized, global Phase III studies riociguat met the primary endpoint, which was a change in exercise capacity after 12 or 16 weeks respectively. Results from the studies, CHEST-1 and PATENT-1, were presented at the 2012 annual meeting of the American College of Chest Physicians (ACCP) in Atlanta, Georgia. Throughout the studies, riociguat was generally well tolerated with a good safety profile.
Positive data from the interim analysis of the ongoing CHEST-2 trial with riociguat was released by Bayer at the 5th World Symposium of Pulmonary Hypertension (WSPH) in Nice, France. Results showed long-term safety and sustained clinical benefits in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Source: Bayer HealthCare
Last Updated: 4/9/13; 10:00AM EST